Inalme’s manufacturing method
Our process, step by step, with full transparency
Identification of clinical or therapeutic need
The identification of the clinical or therapeutic need is a crucial step in the designing and developing process of a product. It is about assessing and understanding the user and customer’s needs in order to provide an appropriate treatment. Once the clinical or therapeutic needs are identified, the design team develops a customised formulation to ensure the best treatment.
Design
Design requires an in-depth understanding of customer’s goals and user’s specific needs. Before proceeding with design, it is important to consider several aspects, through the application of systematic procedures, including formulation, safety, regulatory compliance and effectiveness of the product.
Regulatory compliance
The regulatory compliance of the different products categories represents a crucial aspect to guarantee product safety, effectiveness and commercial success, as well as to avoid legal disputes with competitors or regulatory authorities. Regulations may vary from Country to Country, but there are some general guidelines which are often applied in many jurisdictions. The regulatory team operates with professionalism and it keeps constantly updated with professional advisors, trade associations and regulatory bodies.
Prototyping and industrial scale-up
Prototyping and scale-up activities refer to the transfer process from a pilot scale to an industrial scale. This analysis and related tests are essential for manufacturing large-scale quantities of a product in order to respect its qualitative characteristics and the established times of design and marketing.
Efficacy test
Efficacy tests play a pivotal role in assessing whether the product achieves its stated objectives and offers the promised benefits. Efficacy tests may vary considerably depending on the type of product (medical device, cosmetic, food supplement), but there are some general guidelines that can be applied. A careful planning, the use of scientific methods and a rigorous approach are crucial to ensure that efficacy tests are reliable and significant.
Design, graphics and packaging
Product design, graphics and packaging have a strategic relevance to catch consumers’ attention, to communicate products’ benefits and to convey a sense of trust and quality. Our graphic design team offers these services with a personalised approach able to identify the choices that best suit your needs. These solutions can make the difference for product’s success, by helping to build consumer’s confidence and to communicate brand values.
Manufacturing
Manufacturing stages may vary depending on the type of product and its dosage form (tablets, capsules, solutions). Manufacturing processes are managed with IT infrastructures able to lead the operators through rigorous checks on the quality of process and product. Our commitment at every stage guarantees a safe, effective and compliant product. Quality standards, good manufacturing practices (GMP) and documented procedures are essential for the manufacturing of food supplements, cosmetics and medical devices.
Quality Controls
Rigorous quality controls are carried out throughout the entire product manufacturing process, including component identification, purity, uniformity, stability, environmental controls, process controls, and, in general, all the parameters that may affect product safety and performance.
Placing on the market
The placing on the market of a product is a critical step both for Inalme and for our customers, while the regulatory compliance is an absolute priority. The collaboration between different business functions, included manufacturing, quality and regulatory teams, is essential to ensure the success of this process.
Logistics
Logistics is the stage of the value chain that manages the supply, distribution and stock management of products in a safe, efficient and regulatory compliant manner. Logistics is subject to high standards due to the critical nature of products and regulatory requirements. We take care of the fundamental aspects through suitable storage, transport conditions according to customer’s needs, customised packaging and collaboration with the most important wholesalers and warehouses.
Our certifications
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